APPROVED_FOR_MARKETINGNot Applicable

Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

United States

Plain-language summary

This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects with diagnosed descending thoracic aneurysm or penetrating ulcer * Subjects whose anatomy can accommodate the Relay device * Subjects who consent to participate * Subjects who agree to a follow-up schedule Exclusion Criteria: * Subjects with lesions other than thoracic aneurysm and penetrating ulcer * Subjects with less than 1 year life expectancy * Subjects who are pregnant * Subjects with medical conditions that wold complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease) * Subjects participating in another investigational study

Trial details

NCT IDNCT01327742

SponsorBolton Medical

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Thoracic Aortic Aneurysm trials